N/A
N=284
Stroke Swallowing Screening Tool Validation
Cerebrovascular Disorders · Deglutition Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01559649 ↗Enrolled (actual)
284
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Sensitivity of Screening Items — 37.9; 3.5; 62.1; 10.3 percentage of agreement
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Establishing Validity and Reliability (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Screening Items |
37.9; 3.5; 62.1; 10.3; 27.6; 72.4 | — |
| PRIMARY Specificity of Screening Items |
82.8; 99.5; 80.5; 98.6; 95.9; 59.7 | — |
| PRIMARY Negative Predictive Value of Screening Items |
91.0; 88.7; 94.2; 89.3; 91.0; 94.3 | — |
| SECONDARY Average Accuracy Rate for Nurse Administration for All Screening Procedures |
98.33 | — |
| SECONDARY Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items |
0.394; 0.717; 0.645; 0.360; 0.911; 0.837 | — |
Summary
Stroke is a major medical problem in the United States, and veterans are at significant risk given that the most critical risk factors of stroke, older age and associated medical problems such as high blood pressure, are common. Dysphagia, swallowing problems, can lead to aspiration which in turn may result increased pneumonia, particularly in stroke patients. Development and implementation of an accurate and consistent nursing swallowing screening tool to identify risk of aspiration in individuals admitted with suspected stroke is critical as it allows for immediate intervention, thereby reducing associated medical complications, length of stay, and healthcare costs. The availability of such screening tools, however, is limited. The primary objective of this study is to construct a reliable and valid swallowing screening tool to identify risk of aspiration in individuals admitted with suspected stroke.
Eligibility Criteria
Inclusion Criteria
- Male and female Veterans of all ethnicities admitted to MEDVAMC with a new suspected ischemic or hemorrhagic stroke will be eligible to participate.
- Individuals with a history of prior strokes without dysphagia will be eligible to participate.
- Patients must be medically stable as determined by the attending neurologist.
- Participants with language or cognitive deficits who are judged by the attending neurologist to not have capacity to provide informed consent will be eligible to participate but they must have an authorized representative available within 24 hours of admission to provide consent.
Exclusion Criteria
- Individuals with a history of neurological disease other than stroke, head and neck structural surgery, or history of dysphagia unrelated to the current stroke will be excluded from participation.
- Individuals who are obtunded (unable to maintain wakefulness), currently diagnosed with pneumonia, or on ventilator support will be excluded.
- Veterans who are more than 72 hours past MEDVAMC admission will be excluded.
Data sourced from ClinicalTrials.gov (NCT01559649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.